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02/11 Divya Rajan
Senior Lead/HR Advisor at Recruise India Consulting

Views:637 Applications:98 Rec. Actions:Recruiter Actions:73

Regulatory Writing Role - Clinical Study Reports (3-8 yrs)

Bangalore Job Code: 1334010

Salary offered: 10 LPA to 17 LPA

- Document Preparation, Development and Finalization/Document Management

- Effectively collect and evaluate data, information, and input from multiple sources, functions, and regions to create a cohesive content strategy for writing projects.

- Plan (including organizing/preparing outlines), write (including first-draft authoring), edit, review, coordinate, and complete the regulatory documents supporting clinical development/product registration.

- Conduct effective document initiation meeting to ensure authoring team alignment and understanding.

- Build scientific-based rationale that support the purpose of more complex and/or strategic documents.

- Ensure data are presented in a clear, complete, accurate, and concise manner.

- Ensure that key data, statements and conclusions are consistent across related documents, and that statements and conclusions are integrated, accurate, balanced and supported by appropriate data.

- Coordinate expert/scientific reviews, collate reviewer's comments, adjust content of document as required based on internal/external input, and prepare final version.

- Ensure and coordinate quality checks for accuracy.

- Exhibit flexibility in moving across development and preparation of multiple document types.

- Influence or negotiate change of timelines and content with other team members.

- Work with internal and external experts to develop and prepare presentations.

- As needed, may build and manage relationships with vendors/alliance partners.

Women-friendly workplace:

Maternity and Paternity Benefits

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